483
Biomat USA IncFDA 483 - Biomat USA Inc - February 04, 2026
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An FDA inspection of Biomat USA Inc.'s Source Plasmapheresis Collection Center in Surprise, AZ, revealed significant deficiencies. Observations included a failure to maintain complete donor test records, non-adherence to standard operating procedures for donor arm preparation, and an inadequate SOP for investigating adverse donor reactions. These issues highlight concerns regarding data integrity, procedural compliance, and donor safety.
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